Device Trial Instructions
Prior to enrolling ANY MEDICARE PATIENTS in an IDE, HDE, or Carotid Stent study, you must receive written approval for both Medicare Part A and Part B coverage (Facility and Provider).
Compliance Risk for Improper Billing
If required processes are not followed and/or approvals are not obtained in advance of submitting a claim to Noridian, Medicare's local contractor, the risks to both hospital and physician claims include:
- No payment for services rendered
- Payment denial
- Denial may include up to the full hospital stay and profees
- Improper payment with subsequent repayment
- Possible false claims risk
Required Informed Consent Language for Noridian IDE Submissions
Noridian requires that the Informed Consent contain the suggested language in the approved document.
Suggested language: "The University of Utah Health Care and Principal Investigator receives
funds from the sponsor, (enter sponsor name), to cover costs related to research."
The suggested location of the above language may be entered under the “Cost and Compensation to Participants” in the Informed Consent.
Medicare may provide reimbursement for some investigational devices and related services. Services may be furnished in preparation for device use, contemporaneously with, and necessary to the use of the device, and as follow-up care after device use. Coverage is contingent on the Medicare contractor's approval of the application for reimbursement. Our local Medicare Contractor is Noridian. For additional information please visit the following websites:
- Noridian Part A: Investigational Device Exemption (IDE) Information
- Noridian Part A: Humanitarian Device Exemption (HDE) Information
- Noridian Part A: Post Market Studies & Post-Market Extension Studies
- Noridian Part B: Investigational Device Exemption (IDE) Information
- View answers to your frequently asked questions
- View Medicare and FDA References
Device Trial Steps to Complete Next
If you have questions contact
Kristin Kolsch, FDA Compliance Officer at (801)587-0835.